FDA Device recall Z-0746-2013
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred…
- FDA Device
- Class III
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class III recall of Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred… by Alere San Diego, citing out of range (increased) HDL Cholesterol results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0746-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-22 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
Reason
Out of range (increased) HDL Cholesterol results.
Identifiers
| code_info | Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2013%22
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